Regulatory Update- USA FDA September 2019

This document provides a mapping of the US FDA 21 CFR requirements to the “regulatory requirements” references in ISO 13485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.

It is most needed for US manufacturers but can be relevant for any manufacturer that would like to sell in the USA or US territories. All FDA territories require compliance to 21 CFR 820 for almost all medical devices, a handful of devices are GMP exempt and Class 1 Devices do not require design controls. Other than that, basically all devices whether imported by foreign manufacturers or domestic must adhere to 21 CFR 820.

This standard shows a correlation between 21 CFR 820 and the ISO 13485:2-16 standard.